KR20200132905A - Dose control device for injectable-drug delivery devices - Google Patents

Abstract

A dose control device for a handheld pen type injectable drug delivery device, wherein the handheld pen type injectable drug delivery device has an elongated body having a proximal end and a distal end, a longitudinal axis extending from a proximal end to a distal end, and a proximal end. And a rotating dose setting wheel located, the dose control device comprising: means for generating a magnetic field located at a proximal end of the elongated body; One or more magnetic field sensors in communication with a data processing unit located inside or on the outer surface of the elongated body; And a clutch assembly configured to selectively move the magnetic field generating means from the first, engaged position to a second, disengaged, position.

Description

Dose control device for injectable-drug delivery devices

The present invention relates to injectable-drug delivery devices and in particular to a dose control device provided for such injectable-drug delivery devices.

Injectable drug delivery devices have been known for many years. Allowing users to self-inject their medications as the demand for more patient responsibility for managing patients' own individual treatments and medication plans progresses and develops. Various drug delivery devices have been developed. This is particularly true when using insulin intended to treat the consequences of diabetes, for example. However, for example, it is necessary to address potentially life-threatening situations, anaphylactic shock treatments, anti-coagulants, opioid receptor agonists. And other drugs that allow immediate emergency infusion of required drugs, such as opioid receptor antagonists, etc. are also used by patients suffering from or susceptible to these diseases. They fall into this category to the extent that attending usually occurs.

One of the known problems of existing self-injector systems is accurate and precise dosage control. In previous generations of injectable-drug delivery devices, to prevent or limit excessive dose infusions, or the potentially serious consequences of overuse of the device and of such abuse, misuse, or simple user error. Equipped with mechanical means to try. Additionally, it is thought that it would be desirable to be able to inform the user of the amount of self-injected drug, so that there is at least some degree of visible cue for the injected amount, and therefore facilitates the management of the treatment regime. .

The main problems associated with the proposed mechanical solutions are that they essentially over-complicate the structure of the drug delivery devices, and quite often impose very rigorous or complex ways of working on the user that may differ from what the user is used to, more manipulation Phase errors, loss of drug dosage, patient non-compliance and a number of other difficulties.

To overcome these difficulties, non-contact sensors and device built-in to indicate the frequency and dose amounts of injectable drug administered, wasted, purged or otherwise expelled from the drug delivery device. Through the use of information processing systems, attempts have been made to address the complexity of pure mechanical solutions involving the mechanical interactions of small and fragile components and the movement of mechanical parts. This led to multiple different technical solutions, but each was tailored to specifics corresponding to the corresponding range of injectable-drug delivery devices from a particular manufacturer.

In another embodiment, the sensor circuit may include position sensors configured to monitor certain components of the drive mechanism moving during injection. The position sensors can be linear sensors or rotation sensors, and the specific selection of sensors is chosen depending on the dosage setting and the specific design of the injection mechanism. For example, a linear position sensor can be provided that monitors the movements of the piston rod during injection. Alternatively, the position sensors are provided with a position sensor that records the movement of the moving component in synchronism with the piston rod during injection. For example, a component that is rotatably mounted in the device and rotates during injection may be monitored by a rotational position sensor, and the dosing speed may be calculated from the rotational motion of the rotatably mounted component during injection. .

EP1646844B2 discloses a device for the administration of an injectable drug, comprising a non-contact measuring unit for measuring the position between the elements of the dosing device, the dosing device being movable relative to each other, The measuring unit comprises: a magneto-resistive sensor embodied as a rotating element for measuring a rotational position and movable with respect to the first element, fixed to the first element opposite the second magnetizable element; And a magnet device having a first element and a predetermined surface profile such that when the first element and the second element are moved relative to each other, the surface of the second element changes the distance from the permanent magnet of the first element. And a magnet device formed from a permanent magnet on the second magnetization element; Thus, a measurable change in resistance occurs in the magneto-resistance sensor due to a change in the magnetic field. This is a fairly complex system with many ancillary parts built into the barrel, or body of an injectable-drug delivery device, and the potential failure of various components or movements of magnets and magnetizing elements and It potentially interferes with the interaction between individual signals.

WO2013050535A2 discloses a system comprising a sensor assembly configured to measure a magnetic field, and a movable element configured to be moved relative to the sensor assembly between two positions by a combined shaft and rotational motion, wherein the rotational motion is an axis Has a predetermined relationship to exercise. The magnet is mounted on the movable element and is configured to generate a spatial magnetic field that changes in response to both axial and rotational movements of the magnet and hence the movable element with respect to the sensor assembly. The processor is configured to determine the axial position of the movable element based on the measured values for the magnetic field. In this system the magnetic field generating means are located on a longitudinal drive screw located in the body of the injectable drug-delivery device, and the sensors are located along the longitudinal axis of the drug delivery device. It is noted that the whole of the system is repositioned within the main body of the drug delivery device in order to allow the magnetic field to be created as close as possible to the sensors and the longitudinal axis on which the magnet moves.

WO2014161954A1 discloses a drug delivery system, wherein the housing of the drug delivery device is configured to rotate relative to the housing corresponding to the set and/or discharged dose integrated within the housing, and a first force transmitting surface ) Comprising a first rotational member, a second rotational member configured to rotate with respect to the housing corresponding to the set and/or discharged dose and comprising a second force transmission surface, the first At least a portion of the force transmission surface and the second force transmission surface are configured to engage each other during setting and/or discharging of the dosage, wherein the first rotating member changes in response to the rotational motion of the first rotating member. Comprising a magnet that generates a magnetic spatial field, and the first rotating member is formed entirely from a polymeric material containing magnetic particles, and the polymeric material provides a magnet that generates a spatial magnetic field. Magnetized.

All of the above solutions involve a fairly complex arrangement of the configuration of various sensors and/or elements within the drug delivery device body, which further suggests that the drug delivery device in general has to be modified considerably substantially.

WO2017013464A1 is a dose control device capable of operating with a broad spectrum of currently available injectable drug delivery devices, in which the dose control device is generally mounted at or near the proximal end of an elongated body of a pen-shaped self-injectable drug delivery device. Start. In one embodiment, the dose control device comprises an annular component comprising magnetic field generating means, such as a permanent dipole magnet, the annular component generally extending on a known dose setting wheel forming part of an injectable drug delivery device. At the proximal end of the body, mounted about the longitudinal axis of the elongated body, the annular component rotates with the dose setting wheel. In a housing located near the proximal end of the elongated body, connected to the signal processing unit and located distal from the annular component, the magnetic field detection means calculates values of the magnetic field for all rotation angles of the annular component when the dose setting wheel rotates. It serves to detect. Such a dose control device does not require substantial modification of a drug delivery device for injection or a manner in which it acts on a user, that is, a modus operandi (MO) when compared to a conventional drug delivery device. Moreover, such a device, detachably mounted to the injectable drug delivery device, may be, for example, damage to the injectable drug delivery device or malfunction in the injectable drug delivery device, or simply some injectable drug delivery devices may be Since it is configured to deliver only the available drug dose, it makes it possible to exchange the injectable drug delivery device if it requires switching to another injectable drug delivery device having a different range of available drug doses.

Despite the above progress, some currently available pen-type injectable drug delivery devices may require rotational movement around the longitudinal axis of the magnetic field generating means, and/or translational movement along the longitudinal axis, or It functions in a specific way, which may not be desired and/or required. It is therefore an object of the present invention to provide a dose control device similar to that described above, but still much more advantageous and much greater flexibility and adaptability for various use cases of available pen-type injectable drug delivery devices. These and other objects will become apparent from the various embodiments as shown below and described above.

As indicated above, this flexibility is particularly noteworthy with respect to the motion of the annular component comprising the magnetic field generating means. The main problems can be summarized as follows.

1A) During the dose setting step, that is, when the user sets the dose to be injected by rotating the dose setting wheel, it rotates both clockwise and counterclockwise with the dose setting wheel for the magnetic field generating means, and also The requirement to translate in both the distal and proximal directions with the dose setting wheel along the longitudinal axis;

1B) The requirement that during the dose injection step, ie when the drug is discharged, it does not rotate clockwise or counterclockwise with respect to the magnetic field generating means, and can still only move in a distal direction along the longitudinal axis of the drug delivery device;

2A) A requirement to rotate both clockwise and counterclockwise together with the dose setting wheel for the magnetic field generating means during the dose amount setting step, and also translate both distal and proximal directions along the longitudinal axis of the drug delivery device;

2B) The requirement to rotate with the dose setting wheel only in a single direction corresponding to the selected dose for the magnetic field generating means in the dose injection step, and still move in a distal direction along the longitudinal axis of the drug delivery device;

3A) A requirement to rotate both clockwise and counterclockwise together with the dose setting wheel for the magnetic field generating means during the dose amount setting step, and prohibit translational movement along the longitudinal axis of the drug delivery device in the distal or proximal direction;

3B) In the dose dose injection step, the requirement for the magnetic field generating means is the requirement to rotate with the dose setting wheel only in a single direction corresponding to the selected dose, and still move in the distal direction along the longitudinal axis of the drug delivery device.

Accordingly, one object of the present invention is a dose control device for a handheld pen type injectable drug delivery device, and the handheld pen type injectable drug delivery device includes an elongated body having a proximal end and a distal end, from a proximal end to a distal end. A longitudinal axis extending, and a rotating dose setting wheel located at the proximal end, wherein the dose control device comprises:

Magnetic field generating means located at the proximal end of the elongated body;

One or more magnetic field sensors in communication with a data processing unit located inside or on the outer surface of the elongated body; And

And a clutch assembly configured to selectively move the magnetic field generating means from a first, engaged position to a second, disengaged, position.

Various means for generating a magnetic field are known, for example typical magnets, electromagnets, mixed material magnets. Such magnets are typically made from magnetizing materials, having magnetic or paramagnetic properties to create or induce a magnetic field in the material either naturally or when an electric or other energy flow traverses or affects the material. Suitable materials are:

-Ferrite magnets, in particular sintered ferrite magnets, comprising, for example, crystalline compounds of iron, oxygen and strontium;

-A composite material composed of a thermoplastic matrix and isotropic neodymium-iron-boron powder;

-A composite material composed of a thermoplastic matrix and strontium-based hard ferrite powder, the resulting magnets are isotropic, i.e., non-oriented ferrite particles, or anisotropic, That is, it may contain oriented ferrite particles;

-A composite material made of a thermo-hardening plastic matrix and isotropic neodymium-iron-boron powder;

-Magnetic elastomers, made, for example, of strongly charged strontium ferrite powder mixed with synthetic rubber or PVC; And then extruded into the desired shape or calendered into fine sheets;

-Flexible calendered composites, usually of a brown sheet shape, more flexible or less flexible depending on their thickness and their composition. These composites are by no means elastic as rubber, and Shore Hardness tends to range from 60 to 65 Shore D ANSI. These compositions are generally formed from synthetic elastomers filled with strontium ferrite grains. The resulting magnets can be anisotropic or isotropic, and sheet types generally have magnetic particle alignment due to calendering;

Laminated composites, generally co-laminated with a soft iron-pole plate, including such flexible composites;

-Neodymium-iron-boron magnets;

-Magnetized steels made of aluminum-nickel-cobalt alloy;

-Can be appropriately selected from alloys of samarium and cobalt.

The above list of magnetic field generating means is a magnetic field generating means suitable for use in the present invention, a neodymium-iron-boron permanent magnet, a magnetic elastomer, a composite material composed of a thermoplastic matrix and a strontium-based hard ferrite powder, a thermosetting plastic matrix and isotropic A magnetic field generating means selected from the group consisting of a composite material consisting of neodymium-iron-boron powder is preferred. These magnets are known for their ability to be dimensioned in a relatively small size while maintaining a relatively high magnetic field strength.

The magnet is defined as a general disk shape, which can be of circular, elliptical, or any suitable polygonal shape and has a single dipole, i.e. a single pair of opposite and south magnetic poles. It must be understood. As indicated above, the magnet used in the present invention is substantially disc-shaped, but this substantially disc shape is also substantially the center of the disc to form a ring shaped magnet or an annular shaped magnet. It may include a magnet having an orifice in.

The magnet of the present invention is configured to perform axial rotation and translation around a longitudinal axis of the drug delivery system. The rotational displacement occurs simultaneously with the rotational displacement of the dose setting wheel, meaning that turning or turning the magnet around the longitudinal axis also causes the dose setting wheel to rotate in the same direction of rotation. Typically, the dose setting wheel is attached to a drive shaft or lead screw that traverses the inner bore of the drug delivery device body. The dose control device can also calculate the travel distance of the magnetic field generating means along the longitudinal axis.

Also the magnetic field generating means are dimensioned to provide a sufficient magnetic field to be detected by the magnetic field sensor.

In a dose control device comprising a clutch assembly according to the invention, at least a first magnetic field sensor and a second magnetic field sensor are present and configured to measure the magnetic field generated by the magnet. At least the first magnetic field sensor and the second magnetic field sensor measure the magnetic field generated by the rotational motion of the substantially disc-shaped magnet, and optionally translational motion, and the dose selected for administration via the injectable-drug delivery device. It is used to calculate the angular rotational position of the magnet to determine it accurately. Optionally, and advantageously, such a system can be used to calculate the translational position of a reference point of interest along the longitudinal axis of the drug delivery device body, the reference point being the dose administered, the zero point, It can be used to correlate a priming point or an initialization point for the system, an injection start point and/or an injection end point.

Means for measuring the magnetic field to determine the rotational angular position are generally known in the art. For example, magneto-resistors are known means, some of which are used in prior art systems. These magnetoresistive resistors are often designated as abbreviations, eg AMR sensors, GMR sensors, TMR sensors, and these designate the physical mechanisms that operate these sensor components. GMR (Giant Magnetoresistance) is a quantum mechanical quantum resistance observed in thin-film structures composed of alternating ferromagnetic layers and non-magnetic conductive layers. mechanical magnetoresistance) effect. Anisotropic magnetoresistance, or AMR, is said to exist in materials where the dependence of electrical resistance on the angle between the current direction and the magnetization direction is observed. TMR (Tunnel magnetoresistance) is a magneto-resistance effect that occurs at a magnetic tunnel junction (MTJ), a component composed of two ferromagnets separated by a thin insulator. Resistors themselves are known that utilize their various properties.

In light of the above, the dose control device of the invention preferably uses magnetometers, magnetic field sensors, preferably at least first magnetometers and second magnetometers. These magnetometers differ from GMR sensors, AMR sensors or TMR sensors in that they directly measure the magnetic field strength. Magnetometers measure the magnetic field in two main ways: vector magnetometers measure the vector components of a magnetic field, and full-field magnetometers or scalar magnetometers measure the magnitude of a vector magnetic field. Another type of magnetometer is an absolute magnetometer, which measures the absolute magnitude or vector magnetic field using internal calibration or physical constants of known magnetic sensors. Relative magnetometers are called variometers, which are used to measure magnitude or vector magnetic fields against a fixed but uncalibrated baseline, and also to measure changes in the magnetic field.

A preferred magnetometer for use in the dose control device according to the present invention is an ultra low-power high performance three axis Hall-effect magnetometer. While the magnetometer is configurable to measure the magnetic field across three mutually perpendicular axes or orthogonal axes, even so, the magnetic field sensor is only available in two of the three orthogonal axes, e.g., the X and Z axes. Is preferably configured to measure the magnetic field for, wherein the Y axis is co-axial with the longitudinal axis of the drug delivery device body and thus distance measurements related to the translational motion of the dose selector wheel along the longitudinal axis. Corresponds to a normal that can be calculated as indicated above for the reference point position on the axis.

The dose control device also advantageously comprises an integrated control and data processing unit connected to the magnetic field sensors for processing information received from the magnetic field sensors. This integrated control and data processing unit can be mounted, for example, on a printed circuit board of suitable dimensions to be located on or within the elongated body of the drug delivery device. The integrated control and data processing unit handles all electrical communication and signaling between the different electronic components of the dose control device. It also handles the signals from the autonomous power supply and communication means, for example communicating with the smartphone's local data processing system or remote data processing system, as well as the implementation of the dose management system and the correct magnetization. It is responsible for calculations that allow the location to be calculated and determined. It can be programmed remotely on first use or receive information and updates in a manner similar to other electronic devices today that include integrated control and data processing units. These integrated control and data processing units are known per se, and often include a central processing unit, a real-time clock, one or more memory storage systems and optionally other desired components of communication systems or communication subsystems. And integrate.

In one embodiment of the present invention, the clutch assembly comprises a cylindrical body having a longitudinal inner bore, the magnetic field generating means is located in the bore of the cylindrical body, and the cylindrical body is removably mounted in axial longitudinal alignment around the rotating dose setting wheel. And can be rotated with the rotating dose setting wheel.

In another embodiment of the present invention, the first, engaged, position is the cylindrical body so that any rotational motion of the cylindrical body is directly transmitted to the magnetic field generating means to cause the magnetic field generating means to rotate with the cylindrical body. It is held in the bore of

In another embodiment of the present invention, the second, disengaged, position is the magnetic field generating means so that any rotational motion of the cylindrical body is not transmitted to the magnetic field generating means, so as to prevent rotation of the magnetic field generating means together with the cylindrical body. It is the position held in the bore of this cylindrical body.

In another embodiment of the present invention, the cylindrical body has a distal end, the distal end being configured to mate with the outer surface of the dose setting wheel and to grip the outer surface of the dose setting wheel.

In another embodiment of the invention, the cylindrical body has a proximal end and the proximal end is configured to receive at least a portion of the clutch activation button.

In another embodiment of the invention, the cylindrical body includes a first annular wall extending within and along the bore to the proximal end.

In another embodiment of the invention, the first annular wall is connected to the inner surface wall of the cylindrical body.

In yet another embodiment of the invention, the first annular wall is connected to the cylindrical body inner surface wall through a first annular skirt extending radially outwardly from the first inner annular wall to the cylindrical body inner surface wall.

In yet another embodiment of the present invention, the first annular wall, the first annular skirt and the cylindrical body inner surface wall form an annular groove for receiving at least a portion of the clutch activation button.

In yet another embodiment of the invention, the first annular wall comprises a second annular skirt, located at the proximal end of the first annular wall, projecting radially inwardly into the bore of the cylindrical body from the proximal end of the first annular wall. Include more.

In yet another embodiment of the invention, the annular wall further comprises at least a pair of clutch tooth projections extending radially inwardly into the bore of the cylindrical body from an inner surface of the proximal end of the annular wall.

In another embodiment of the present invention, the second annular skirt further comprises a second annular wall extending from the inner end of the second annular skirt, the second annular wall toward the proximal end of the cylindrical body. And extend coaxially.

In another embodiment of the invention, the second annular wall comprises at least a pair of clutch tooth protrusions extending radially inwardly into the bore of the cylindrical body from the inner surface of the second annular wall.

In yet another embodiment of the invention, the distal end of each of the tooth protrusions of the at least a pair of clutch tooth protrusions has a narrower cross-section and/or profile than the cross-section of the tooth protrusion at its proximal end.

In another embodiment of the present invention, the distal end of each of the tooth protrusions of the at least a pair of clutch tooth protrusions is rounded.

In another embodiment of the invention, the clutch assembly further includes a magnetic field generating means holder.

In another embodiment of the present invention, the magnetic field generating means holder comprises a holder body having a longitudinal bore, a proximal end and a distal end.

In yet another embodiment of the invention, the magnetic field generating means holder body comprises a magnetic field generating means material.

In another embodiment of the invention, the holder body comprises a skirt and is positioned adjacent to the distal end of the holder body, the skirt being a substantially planar surface extending radially outwardly from the holder body and a peripheral edge of the substantially planar surface. And an annular peripheral wall extending from the end to the end.

In another embodiment of the present invention, the skirt comprises at least one seating means for magnetic field generating means located in the inner volume defined by the skirt, the seating means receiving the magnetic field generating means in the skirt It is configured to sit.

In another embodiment of the invention, the holder body further comprises an array of clutch tooth protrusions extending radially outwardly in a spaced relationship from the outer peripheral surface of the holder body and positioned around the outer peripheral surface of the holder body.

In yet another embodiment of the invention, the array of clutch tooth protrusions is optionally engageable with at least a pair of clutch tooth protrusions, extending radially inward from the inner surface of the proximal end of the annular wall of the cylindrical body and at least It is possible to disengage from a pair of clutch tooth protrusions.

In yet another embodiment of the present invention, the holder body further comprises an activation button engagement member configured to engage and retain the clutch activation button.

In yet another embodiment of the invention, the clutch activation button engagement member is located within a bore of the holder body adjacent its proximal end.

In another embodiment of the invention, the clutch assembly further includes a clutch activation button.

In yet another embodiment of the present invention, the clutch activation button has a distal end comprising a distal surface, and in the clutch assembly disengaged position, the distal surface contacts a corresponding proximal surface located at the proximal end of the cylindrical body and , In the clutch assembly engaged position, the distal surface of the proximal end of the clutch activation button is no longer in contact with the corresponding proximal surface located at the proximal end of the cylindrical body.

In another embodiment of the invention, the clutch activation button comprises a button body, the button body extending from the proximal end toward the distal end of the button body, and the button body is an annular wall extending distally along the longitudinal axis of the button body. A protrusion, wherein the annular wall protrusion has a diameter less than the diameter of the button body, which is spaced from the proximal end of the button body and forms a distal shoulder at a distal position, the distal shoulder being the cylindrical body at the clutch assembly disengaged position. Dimensioned to contact a corresponding proximal surface located at the proximal end of the.

In another embodiment of the present invention, the annular wall of the activation button body is brought into contact with the annular groove formed by the first annular wall, the first annular skirt and the inner surface wall of the cylindrical body at the clutch assembly disengaged position. It has a distal end surface.

In another embodiment of the invention, the annular wall protrusion of the activation button body defines an inner, inner, substantially cylindrical volume of the annular wall protrusion, and the inner volume has an open distal end and a closed proximal end.

In another embodiment of the present invention, the activation button comprises a holder engagement member, configured to hold and engage the activation button engagement member provided in the magnetic field generating means holder.

In yet another embodiment of the present invention, the clutch assembly further comprises a pre-constrain bias member positioned between the clutch activation button and the annular skirt projecting radially inward from the annular wall adjacent the proximal end of the cylindrical body. do.

In yet another embodiment of the present invention, the pre-pressed biasing member lies distal to the annular skirt of the annular wall of the cylindrical body and proximally with respect to the closed proximal end of the inner volume thereof. It is inserted into a cylindrical volume.

In another embodiment of the present invention, the pre-pressed bias member adopts a relatively uncompressed form in the disengaged clutch assembly position, and adopts a relatively urged form in the engaged clutch assembly position. .

In another embodiment of the present invention, when in the disengaged clutch assembly position, the pre-pressed bias member is compressed.

In another embodiment of the present invention, when in the engaged clutch assembly position, the pre-pressed bias member is relaxed.

In yet another embodiment of the present invention, application of a distal force to the activation button causes compression of the pre-pressed bias member, thereby causing the protruding teeth of the holder to contact the corresponding protruding teeth of the cylindrical body. Disengage and move the distal end surface of the clutch activation button annular wall to contact the annular groove formed by the first annular wall, the first annular skirt and the cylindrical body inner surface wall.

In another embodiment of the present invention, the relief of the compression for the pre-pressed bias member is relatively uncompressed or expands in a relaxed form, causing the clutch activation button to move proximally, and the holder engagement member and The engagement connection between the activation button engagement members also causes the holder to move proximally, engaging the protruding teeth of the holder into a bias contact with the corresponding protruding teeth of the cylindrical body.

In another embodiment of the present invention, the pre-compression bias member is a spring.

A suitable selection can be made by a person skilled in the art as long as the nature and type of the pre-pressed biasing member is considered. However, for the purposes of the present invention, it has been found that flat wire compression springs or wave springs are advantageous as pre-pressed bias members. Such flat wire compression springs, or wave springs, are generally known in the art and are available, for example, from Smalley Steel Ring Company under CM and CMS range identification, CM refers to flat-ended wave spring and CMS Means shim-end wave spring. These springs are generally made of carbon steel or stainless steel.

In an alternative object of the present invention, the dose control device does not interact with the protruding teeth, but instead the cylindrical body further comprises a friction layer located on the inner wall of the proximal end. The cylindrical body can be deformed at the distal end through the provision of a friction layer as an alternative to the means of toothed engagement, but still allows for selectable engagement or disengagement between the magnetic field generating holder body and the clutch activation button. Let's do it. The friction layer is created as a cylindrical body when the skirt surface is combined with the friction layer, and provided with any suitable material that provides sufficient frictional engagement resistance to promote solidary co-rotational motion of the skirt surface of the holder body. Can be. While a variety of suitable friction-inducing materials will enable this function, Applicants believe that the friction layer is a relatively hard material, as opposed to a relatively high shear modulus polymeric material, e.g. 0 Shore A, which has a gel-like concentration. It has been found that particularly suitable friction engagement can be achieved when including materials with a Shore hardness between D. These polymers are known as thermoplastic elastomers or TPA for short, and are generally classified into six groups.

-Styrene block copolymers, also known as TPS or TPE-s;

-Thermoplastic polyolefin elastomers, also known as TPO or TPE-o;

-Thermoplastic vulcanizates, also known as TPV or TPE-v;

-Thermoplastic polyurethanes, also known as TPU;

-Thermoplastic co-polyester, also known as TPC or TPE-E;

-Thermoplastic polyamides, also known as TPA or TPE-a; And

-Unclassified thermoplastic elastomers, also known as TPZ.

While many of the above materials may be compatible with the expected function, Applicants include or consist of styrene block copolymers, in particular polystyrene-b-poly(ethylene-butylene)-b-polystyrene (also referred to as SEBS polymer), and friction layer As a preferred material, it retains members from materials with a Shore A hardness of about 40 to about 80, available for example under the brand name Kraton-G (Shell Chemicals).

As mentioned above, the friction layer is advantageously located on the inner surface of the proximal end of the cylindrical body. In this regard, the friction layer may be provided in the form of a continuous layer, a semi-continuous layer, or a deposit of friction-inducing material, so that each of these and any layers is the thickness of the layer or deposit to produce the required friction effect. Is adjusted. Preferably, the friction layer is an annular-shaped layer of SEBS material which also lies on the inner surface of the proximal end of the cylindrical body through the sheeting means. The sheeting means may for example be a sealant or adhesive disposed and/or dispensed on the inner surface and/or the proximal surface of the friction layer in contact with the inner surface. However, preferably, the applicant has found that it is advantageous to provide a sheeting means as dovetail extensions or protrusions of friction material that finds and extends the corresponding opening provided at the proximal end of the cylindrical body.

The invention will now be described in more detail in conjunction with the accompanying drawings, which are provided for purposes of illustration and demonstration.
1 is a schematic, cross-sectional view of a dose control device according to the present invention for a handheld pen type injectable drug delivery device.
Fig. 2 is a schematic, cross-sectional close-up view of the dose control device of Fig. 1, illustrating the clutch assembly of the dose control device in a first, engaged position.
Fig. 3 is a schematic, cross-sectional close-up representation of the dose control device of Fig. 1, illustrating the clutch assembly of the dose control device in a first, disengaged position.
4 is a schematic, cross-sectional close-up view of the dose control device of FIG. 1 illustrating the relative position of the dose control device after activation of an injection step of a handheld pen type injectable drug delivery device.
5 is a schematic, exploded view of the device according to the invention, along a line of sight from a proximal end to a distal end of the dose control device.
6 is a schematic, exploded view of the device according to the invention, along a line of sight from the distal end to the proximal end of the dose control device.
Fig. 7 is a schematic, cross-sectional close-up view of a dose control device according to the invention similar to that shown in Fig. 2, with different clutch assemblies in a first, engaged position.
Fig. 8 is a schematic, cross-sectional close-up view of the dose control device of Fig. 7 illustrating the clutch assembly of the dose control device in a second, disengaged position.
9 is a schematic, cross-sectional close-up view of the dose control device of FIG. 7 illustrating the relative position of the dose control device after activation of an injection step of a handheld pen type injectable drug delivery device.
Fig. 10 is a schematic, exploded view of the device, with the alternative clutch assembly of Fig. 7, along a line of sight from the proximal end to the distal end of the dose control device according to the present invention.
11 is a schematic, exploded view of the device, with the alternative clutch assembly of FIG. 7, along a line of sight from the distal end to the proximal end of the dose control device according to the invention.

The dose control device according to the invention will now be described in more detail with reference to the drawings. In FIG. 1, a dose control device 1 for a handheld pen type injectable drug delivery device 2 is shown. For example, an automatic injector for self-injection of drugs such as insulin, for example a handheld pen-type injectable drug delivery device, in which the drug is generally dosed in this manner, is generally located at the proximal end 4. As known from existing drug delivery devices such as automatic injectors, an elongated body (3) having a proximal end (4) and a distal end (5), extending from the proximal end (4) to the distal end (5). And a vertical axis 6, and a dose setting wheel 7. The dose setting wheel 7 also includes a dose activation button 21 known generally from several autoinjector drug delivery devices. The dose activation button 21 serves to activate injection of a drug from the drug delivery device 2.

The dose control device is generally a means for generating a magnetic field (8) located at the proximal end (4) of the elongated body (3), data processing located on the outer surface (9) of the elongated body (3), or located inside And one or more magnetic field sensors (not shown) in communication with the unit (not shown). In Fig. 1, magnetic field sensors and data processing unit are shown on the outer surface 9 and the outer surface of the elongated body 3 of the drug delivery device 2, as demonstrated and illustrated in the patent application published as WO2017013464A1. 9) It is located in a housing 10 located around it. However, these sensors and data processing unit can be directly integrated into the body 3 of the drug delivery device.

In addition to the general representation of the dose control device as described here, the dose control device selectively moves the magnetic field generating means 8 from the first, engaged, position to the second, disengaged, position. It is further defined by a clutch assembly 11 configured to. The clutch assembly comprises a cylindrical body 12 having a longitudinal inner bore 13, and the magnetic field generating means 8 are located in this bore 13. The cylindrical body 12 is detachably mounted on the longitudinal axis 6 and the longitudinal axis alignment around the rotational dose setting wheel 7 and can rotate with it. The first, engaged position is the position at which the magnetic field generating means 8 is held in the bore 13 of the cylindrical body 12, and all rotational motions of the cylindrical body 12 are directly directed to the magnetic field generating means 8 It is transmitted to cause the magnetic field generating means to rotate together with the cylindrical body 12. This first, engaged position is illustrated in FIG. 2.

The second, disengaged position is the position at which the magnetic field generating means 8 is held in the bore 13 of the cylindrical body 12, so that any rotational motion of the cylindrical body 12 is the magnetic field generating means 8 Is not transmitted to, thereby preventing the magnetic field generating means 8 from rotating with the cylindrical body 12. This second, disengaged position is shown in FIG. 3.

2, 3 and 4 show close-up views of a proximal portion of the drug delivery device 2 and a detail of the dose control device 1.

The cylindrical body 12 has a distal end 14 configured to mat and grip the outer surface 15 of the dose setting wheel 7 in a removable manner. As an example of a suitable configuration for making this possible, the cylindrical body 12 has an inner diameter or bore slightly smaller than the corresponding outer diameter of the dose setting wheel 7 at the distal end 14, and a close distance from the distal end 14. It is possible to form a resiliently engaging wall 16 that can have an inner annular shoulder 17 provided in position. In this way, when the cylindrical body 12 is inserted onto and around the dose setting wheel 7, when the shoulder 17 is engaged adjacent to the proximal surface 18 of the dose setting wheel 7 Until then, a gradual elastic engagement is caused by the increased friction between the inner surface 19 of the wall 16 and the outer surface 15 of the dose setting wheel 7.

Alternatively, the inner surface of the wall may include protruding lugs, projecting inwardly into the bore and onto the outer surface of the dose setting wheel. In a similar and corresponding manner, the outer surface of the dose setting wheel is, in a longitudinal direction along the longitudinal axis 6 or otherwise in a functionally equivalent manner, the corresponding mating grooves 20 or, for example, the dose It is possible to have pockets extending in a spaced relationship around the outer surface 15 of the setting wheel 7.

When the dose setting wheel 7 rotates, the cylindrical body 12 also rotates to the same degree, or vice versa, that is, when the cylindrical body 12 rotates, this rotation is also to the same degree as the dose setting wheel 7 With the result of being imposed, the cylindrical body 12 is thus rigidly but movably held on the dose setting wheel 7 to allow the user to set the dose to be administered by the drug delivery device, and the usual It does not interfere with the modus operandi (MO).

The cylindrical body 12 also has a proximal end 22, which is configured to receive at least a portion of the clutch activation button 23. Receiving the clutch activation button 23 can be achieved by providing a first annular wall 24 at the proximal end 22 of the cylindrical body 12, the first annular wall 24 within the bore 13 And extends along the bore 13 toward the proximal end 22. The first annular wall 24 is, for example, via a first annular skirt 25 extending from the first annular wall 24 to the cylindrical body inner surface wall 15, or alternatively/in addition, Through the thickened portion 26 of the inner surface wall 15 it is connected to the inner surface wall 15 of the cylindrical body 12 and bears on the inner surface wall 15. In this way, the first annular skirt 25 and the cylindrical body inner surface wall 15 form an annular groove 27 for receiving at least a distal portion of the clutch activation button 23.

In addition, the first annular wall 24 further comprises a second annular skirt 28, located at the proximal end 29 of the first annular wall 24, from which the first annular wall proximal end 29 It protrudes radially inward into the bore 13 of the cylindrical body 12. The second annular skirt 28 further comprises a second annular wall 30 extending from the inner end of the second annular skirt 28, the second annular wall 30 being the proximal end of the cylindrical body 12 ( 22) extends coaxially with the first annular wall facing towards.

As illustrated in more detail in the expanded views of FIGS. 5 and 6, the clutch assembly 11 includes a holder body 32 having a longitudinal bore 33, a proximal end 34 and a distal end 35. It further comprises a magnetic field generating means holder (31). The magnetic field generating means holder 30 is located in the bore 13 of the cylindrical body 12 and is configured to hold or seat the magnetic field generating means 8, or otherwise at least partially comprise the magnetic field generating means material at least partially. Is configured to As illustrated by the figures, the magnetic field generating means 8 is a disk, preferably a disk-shaped dipole magnet 8 having only a single north and south poles arranged in a 180-degree opposite manner, half of the disk being the north pole and the disk The other half is Antarctica. Alternatively, the magnetic field generating means holder body 32 is at least partially made of a magnetic field generating means material, for example a thermo-formed or thermo-formed plastic in which particles are generally embedded or distributed which can be magnetized or magnetized. It can be constructed by a material such as a constructed, known suitable plasto-magnetic material. In the figures the holder body 32 comprises a skirt 36, located adjacent to the distal end 35 of the holder body 32, the skirt 36 extending radially outwardly from the holder body 32. A substantially planar surface and an annular peripheral wall 37 extending distally from the peripheral edge 38 of the substantially planar surface.

The skirt 36 of the magnetic field generating means holder body 32 further comprises at least one seating or locating means 39 for the magnetic field generating means 8, wherein the seating or locating means is the skirt 36 ), and configured to receive and seat the magnetic field generating means 8 in the skirt 36. 5 and 6, the seating means 39 is, for example, by means of an outer peripheral surface of the disk-shaped magnetic field generating means 8 and elastic engagement with the seating or locating means 39, The magnetic field generating means 8 comprises one or more rising or protruding edges located circumferentially around the inside of the inner volume of the skirt 36, which are inserted therein or alternatively fixed thereon.

The holder body 32 also extends radially outwardly in a spaced relationship from the outer, peripheral surface 41 of the holder body 32, and a clutch located around the outer peripheral surface 41 of the holder body 32 It further comprises an array of tooth protrusions 40. This array of clutch tooth protrusions 40 projects inwardly from the first annular wall and extends radially inward from the inner surface 43 of the proximal end 44 of the second annular wall connected to the cylindrical body 12, At least one corresponding pair of clutch tooth protrusions 42 is selectively engaged and disengaged therefrom. The distal end 44 of each tooth protrusion 42 of the at least one pair of clutch tooth protrusions 42 has a narrower cross-section and/or profile than the cross-section of the tooth protrusion 42 at the proximal end 45. Preferably, the distal end of each of the at least a pair of tooth protrusions 42 of the clutch tooth protrusions 40 is rounded. In a similar but opposite manner, the clutch tooth protrusions 40 of the magnetic field of the magnetic field generating means holder body 32 have a proximal end 46 and a distal end 47. The proximal end 46 of the clutch tooth protrusions 40 of the magnetic field generating means holder body 32 has a narrower cross-section and/or profile than that of the same tooth protrusion 40 at the double circular end 47. This arrangement can be activated, for example, by the clutch assembly to move the magnetic field generating means from the first, engaged, position, to a second, disengaged position, and then again from the second, disengaged position. Cooperative sliding engagement of the various tooth protrusions 40, 42 upon the occurrence of partial axial misalignment of the cylindrical body teeth 42 and holder teeth 40, which may occur after being reactivated to move to an engaged position. And disengagement.

The holder body 32 also includes a clutch activation button engagement member 48 configured to engage and retain the clutch activation button 23. As illustrated in FIG. 5, this engagement member 48 is spaced apart from the holder skirt 36 by a protrusion extending in the proximal direction toward the proximal end of the holder 34, It is provided inside the bore 33. In Fig. 5, the clutch activation button engagement member 48 is presented as having a substantially cross-sectional cross-section centered at and oriented, and four evenly spaced block-like protrusions 50 are bore 33 ), with a cylindrical rod-shaped protrusion 49 in the center and directed along the longitudinal axis 6, extending radially outwardly into ), it is presented as having a substantially cross-sectional shape.

As mentioned above, the clutch assembly further includes a clutch activation button 23. The clutch activation button has a distal end 51 comprising a distal surface 52, and when the clutch assembly is in the disengaged position, the distal surface 52 is at the proximal end 22 of the cylindrical body 12. It is brought into contact with a corresponding proximal surface 53 located adjacent thereto. When the clutch assembly is in the engaged position, the distal surface 52 of the distal end 51 of the clutch activation button 23 is no longer in contact with the corresponding proximal distal surface 53 located at the proximal end of the cylindrical body. Does not. The clutch activation button also comprises a button body 54, the button body extending from the proximal end 55 of the clutch activation button 23 towards the distal end 51 of the button body and extending the longitudinal axis of the button body 54. And an annular wall 56 extending away along it. The button body annular wall 56 has a diameter smaller than the diameter of the button body 54, thereby forming a distal shoulder 57 at a position spaced apart from and away from the proximal end 55 of the button body 54. This distal shoulder 57 is dimensioned to contact a corresponding proximal surface 58 located at the proximal end 22 of the cylindrical body 12 when the clutch assembly 11 is in the disengaged position. However, when the clutch assembly is in the engaged position, the distal shoulder 57 and the proximal surface 58 are not in contact with each other, leaving a gap between the two. The annular wall 56 of the activation button body 54 has a distal end surface 52 in a disengaged position in the clutch assembly, and the first annular wall 24, the first annular skirt 25 and inside the cylindrical body It comes into contact with the annular groove 27 formed by the wall 15. The annular wall 56 of the clutch activation button body 54 also defines an inner, substantially cylindrical volume of the annular wall 56, the inner volume having an open distal end 59 and a closed proximal end 63. Have. The holder engagement member 60 comprises a forked cylindrical protrusion 61 located within the inner volume and extending from the closed proximal end 63 of the inner volume to the open distal end 59 as illustrated. And, the split cylindrical protrusion 61 is a protrusion 49 such as a cylindrical rod and at least some of the block-shaped protrusions 50 of the four activation button engagement members 48 provided on the magnetic field generating means holder 31 Molded and dimensioned to hold, surround and engage.

As can also be seen from the drawings, the clutch assembly 11 includes a second annular skirt 28 projecting radially inwardly from the first annular wall 24 adjacent the proximal end 22 of the cylindrical body 12 and the clutch activation. It further comprises a pre-pressing bias member 62 located between the buttons 23. As shown in the figures, the pre-pressed biasing member 62 rests away from the second annular skirt 28 of the first annular wall of the cylindrical body 12. A pre-pressed biasing member is also located around the second annular wall 30 and can be relaxed and compressed around the second annular wall 30. At the same time, the pre-pressed biasing member 62 is inserted into the inner, substantially cylindrical volume 23 of the clutch activation button 23 so as to lie proximally against the closed proximal end 63 of the inner volume and 23). This arrangement can be clearly seen in FIGS. 3 and 4. In the disengaged clutch assembly position, the pre-compressed bias member 62 adopts a relatively compressed or compressed form as illustrated in FIG. 3, and in the engaged clutch assembly position, as illustrated in FIG. Together, they are relatively uncompressed or relaxed.

The function of the clutch assembly can be summarized as follows:

The application of a force to the clutch activation button 23 in the distal direction, for example the push of the user's thumb or finger, causes compression of the pre-pressed biasing member 62, resulting in a corresponding protruding tooth 42 of the cylindrical body 42 ) Causes disengagement of the teeth 40 protruding of the holder 31 from the biasing contact with). At the same time, the distal end surface 52 of the clutch activation button body comes into contact with the annular groove 27 formed by the first annular wall 26, the first annular skirt 28 and the cylindrical body inner surface wall 15. ;

The relaxation of the compressive force on the pre-pressed bias member 62 is, for example, by alleviating the thumb or finger pressure applied in the distal direction by the user, so that the biasing member 62 is relatively uncompressed or relieved, Inflates or decompresses into shape, causing the clutch activation button 23 to move proximally. As the engagement connection between the holder engagement member 48 and the clutch activation button engagement member 60 holds the two members together, the proximal movement of the clutch activation button 23 causes the holder to move in the proximal direction. It is also moved so that the protruding teeth 40 of the holder 31 are brought into bias contact with the corresponding protruding teeth 40 of the cylindrical body 12 to engage once more. Pre-pressed biasing members suitable for use in the present device are springs, preferably flat wire compression springs or wave springs. Flat wire compression springs are particularly advantageous in the present invention because they allow the development of a sufficient range of compression and relaxation along short distances for relatively very small diameters.

In use, the dose control device with the clutch assembly functions as follows:

2 shows the clutch assembly 11 in a pre-mounted and ready-to-use state, typically found when a user removes the drug delivery device 2 from the packaging. Mounting of the clutch assembly 11 with the dose setting wheel 7 generally occurs during the packaging of the drug delivery device, for example at the production site of the drug delivery device 2. However, since the clutch assembly 11 is also removable, after use of the drug delivery device, it can be removed for disposal, eg recycling. Alternatively, the clutch assembly may be configured with any other mountable component of the dose control device, such as one or more magnetic field sensors in communication with the data processing unit as described in WO2017013464A1, when preparing the drug delivery device for use. It can also be installed by the user together. As illustrated in FIG. 2, in any case, the clutch assembly is mounted on and around the dose setting wheel 7. The cylindrical body extends from the distal end 14 to the proximal end 22, so that the distal end 14 is substantially aligned with the distal end of the dose setting wheel 7. Thus, the cylindrical body 12, when mounted on the drug delivery device 2, extends in a proximal direction from the distal end 64 of the dose setting wheel, beyond the proximal end 65 of the dose setting wheel 7 The standing, standing, proximal end 65 has an exposed proximal surface 18 that engages adjacent the shoulder 17 of the cylindrical body. For drug delivery, injection, or dose activation, a button 21 is positioned in contact with the dose setting wheel 7 and forms an integral part of the drug delivery device 2. The clutch activation button 23 and the magnetic field holder 31 adjacent to the proximal end 22 of the cylindrical body are engaged with each other through the respective engagement members 48, 60, and the magnetic field holder 31 is a clutch activation button. It is maintained by (23). The pre-pressed bias member 62, in this case a flat wire compression spring, is in a relatively uncompressed or relaxed form, around the second annular wall 30, the proximal surface of the second annular skirt 28 Is placed far away. Although not shown in FIG. 2, the spring extends proximally in an uncompressed or relaxed form at all times to rest on or abut against the medial volume proximal end 63. As can be seen from Fig. 2, the holder 31 is not pressed by the pre-restriction imposed on the spring 62 so that the protruding teeth 40 of the holder 31 engage the protruding teeth 42 of the cylindrical body. In or in a relaxed form, it is pulled to the clutch activation button 23 through the engagement connection 48, 60 of the holder. The distal face 52 of the button body 54 remains in the annular groove 27, adjacent to its proximal end, and adjacent to the proximal end 22 of the cylindrical body 12. This represents the first, engaged position because any rotational motion imparted to the cylindrical body 12 is also transmitted directly to the magnet 8 through the mutual coupling of the respective engaged teeth 40, 42. The rotation of the magnet 8 causes a change in the distribution of the magnetic field components generated in three dimensions around the axis of rotation of the magnet, coincident with the longitudinal axis 6 of the drug delivery device 2, and these changes It is detected by a magnetic field sensor located on the body. The rotation of the dose wheel also sets the dose of the unit drug administered through the drug delivery device in a known manner. Once the desired dose has been set, the user presses the clutch activation button proximal end 55 with a thumb or finger to move the distal clutch assembly to the disengaged position. As can be seen from Fig. 3, in the disengaged position, the clutch activation button 23 has been depressed by the user. The button moves and compresses against the pre-pressed bias member 62, moving the spring from a relaxed or uncompressed form to a compressed or compressed form. Accordingly, the distal surface 52 of the button body 54 moves deep into the annular groove, so that the distal surface 52 finally engages adjacent to the proximal surface of the first annular skirt 25 of the cylindrical body 12 or Engages are almost adjacent. Likewise, the distal shoulder 57 of the button body 54 enters a surface that engages adjacent the proximal surface 58 located at the proximal end 22 of the cylindrical body 12. During the distal movement, the protruding teeth 40 of the holder 31 are pushed out of the engagement and contact with the protruding teeth 42 of the cylindrical body 12, but still each and the corresponding engagement members 48, 60 Remains connected to the clutch activation button via. This position is the second, disengaged position. As long as finger or thumb pressure by the user on the clutch activation button is maintained in the distal direction, the second, disengaged position is forced. Also, in the disengaged position, the magnet 8 without any adjacent engagement between the protruding teeth 40, 42 is now no longer affected by any rotational motion applied to the cylindrical body, and if desired, the magnet It is also noted that the cylindrical body and the corresponding dose setting wheel can be rotated without affecting the three-dimensional magnetic field components generated by (8). It is also noted that in the disengaged position, the distal surface 66 of the magnet 8 comes into contact with or very close to the proximal surface of the drug delivery activation button 21. Thus, it is now possible to activate drug delivery within the drug delivery device by continuing to apply distal oriented pressure to the clutch activation button 23. This distal oriented pressure supports the distal surface 66 of the magnet 8 on the drug delivery activation button 21, causing the clutch assembly to move in the distal direction. As the drug delivery activation button 21 contacts the dose setting wheel 7 and the injection barrel 67 of the drug delivery device, these elements also advance in the distal direction to result in injection and delivery of the drug from the drug delivery device. . The final position of the clutch assembly 11 at the end of the injection phase, the dose setting wheel and the drug delivery activation button 21 are illustrated in FIG. 4. After the injection is complete, the pressure on the clutch activation button 23 is relieved or abandoned, and the pre-pressed biasing member 62 biases the holder 31 connected with the clutch activation button again in the proximal direction, and a corresponding protruding tooth Bring the clutch assembly 11 together with the 40 to the holder 31 and move the clutch assembly 11 to a first, engaged position, where each of the protruding teeth 40, 42 is once again engaged adjacent to each other. Rotation of the cylindrical body once again causes the magnet 8 to rotate, causing the dose setting wheel to be used to further prepare for administration of the drug.

Referring now to Figs. 7, 8, 9, 10 and 11, the dose control device according to the present invention comprises an alternative clutch assembly as will be described below. It is illustrated. Similar reference numbers will be used to refer to similar elements of the device.

FIG. 7 shows this alternative clutch assembly mounted to the cylindrical body 12 in an engaged position with the spring 62 in a relaxed or substantially uncompressed form similar to FIG. 2. In this position, the spring 62 biases the clutch activation button 23 away from the cylindrical body in the proximal direction along the longitudinal axis 6 of the dose control device 1. The clutch activation button 23 has a distal end 51 comprising a distal surface 52 as shown in FIG. 2. When the clutch assembly is in the engaged position, the distal surface 52 of the distal end 51 of the clutch activation button 23 is a corresponding proximal end surface located at the proximal end 22 of the cylindrical body 12 ( 53) Do not contact with. The clutch activation button 23 also comprises a button body 54, the button body extending from the proximal end 55 of the clutch activation button 23 toward the distal end 51 of the button body 54, and the longitudinal axis (6) and coaxially aligned with, an annular wall extending distally along the longitudinal axis of the button body 54. It is, for example, in the default resting position of the clutch assembly before the device administers the injection, or alternatively when the user of the drug delivery device performs the injection. In this alternative embodiment of the clutch assembly, there is no interaction of sets of engagement teeth provided on the magnetic field body 31 on one hand and on the cylindrical body on the other. Instead, the engagement by a friction layer 68 located on the inner surface 69 of the proximal end 22 of the cylindrical body 12, as will be described in more detail below in connection with FIGS. 10 and 11. Means are provided.

8 shows the relative position of the clutch assembly and the dose control device when the clutch assembly is in a disengaged position where the user prepares the drug delivery device for injection. In this position, the spring 62 is in a compressed or substantially compressed form, and the distal surface 52 of the distal end 51 of the button body 54 is adjacent to the proximal end 22 of the cylindrical body 12. It is brought into contact with the located corresponding proximal surface 53. As long as finger or thumb pressure by the user on the clutch activation button is maintained in the distal direction, the second, disengaged position is forced. Further, in the disengaged position, the magnet 8 adjacent between the protruding teeth 40, 42 and without any engagement is now no longer affected by any rotational motion applied to the cylindrical body, and Note that, if desired, the corresponding dose setting wheel can be rotated without affecting the three-dimensional magnetic field component generated by the magnet 8. It is also noted that in the disengaged position, the magnet 8 is in contact with or very close to the proximal surface of the drug delivery activation button 21.

As a result, it now becomes possible to activate drug delivery in the drug delivery device by continuing to apply a distal oriented pressure on the clutch activation button 23. This distal oriented pressure causes the clutch assembly to support the distal surface 66 of the magnet 8 to the drug delivery activation button 21 and move in the distal direction. Since the drug delivery activation button 21 is in contact with the dose setting wheel 7 and the injection barrel 67 of the drug delivery device, these elements are also distal to result in injection and delivery of the drug from the drug delivery device. Go ahead. Accordingly, FIG. 9 shows the relative positions of the clutch assembly and the dose control device after the user receives such an injection.

10 and 11 show schematic exploded and more detailed perspective views of an alternative clutch assembly along the longitudinal axis of the device viewed in a first direction and a second opposite direction. In these figures, the cylindrical body 12 is deformed at its distal end 22 through the provision of a friction layer 68 and generates a magnetic field as an alternative to the toothed engagement means described with reference to the previous embodiment. The holder body 32 and the push button 23 can be selected and engaged. This provides sufficient frictional mating resistance to promote joint co-rotation of the proximal outer surface 69 of the magnetic field generating holder body 32 together with the cylindrical body when this proximal outer surface 69 is engaged with the friction layer 68. It can be provided by any suitable material provided. While a variety of suitable friction-inducing materials will enable this function, Applicants believe that the friction layer 68 has a Shore hardness between 70 Shore D, a relatively strong material in contrast to 0 Shore A, which is for example gel-like. It has been found that particularly suitable frictional engagement can be achieved when including a relatively high shear modulus polymeric material. These polymers are known as thermoplastic elastomers or TPE for short and are generally classified into six different groups:

-Styrene block copolymers, also known as TPS or TPE-s;

-Thermoplastic polyolefin elastomers, also known as TPO or TPE-o;

-Thermoplastic vulcanizates, also known as TPV or TPE-v;

-Thermoplastic polyurethanes, also known as TPU;

-Thermoplastic co-polyester, also known as TPC or TPE-E;

-Thermoplastic polyamides, also known as TPA or TPE-a; And

-Unclassified thermoplastic elastomers, also known as TPZ.

While many of the above materials may be compatible with the expected function, Applicants include or consist of styrene block copolymers, in particular polystyrene-b-poly(ethylene-butylene)-b-polystyrene (also referred to as SEBS polymer), and friction layer As a preferred material, it retains members from materials with a Shore A hardness of about 40 to about 80, available for example under the brand name Kraton-G (Shell Chemicals).

As mentioned above, the friction layer 68 is located on the inner surface 69 of the proximal end 22 of the cylindrical body 12. In this regard, the friction layer may be a continuous layer, a semi-continuous layer, or may be provided in the form of an array of deposits of a material causing friction, so that each of them is all of the layer or deposit to produce the required friction effect. The thickness is adjusted. Preferably, the friction layer 68 is an annular-shaped layer of SEBS material which also lies on the inner surface 69 of the proximal end 22 of the cylindrical body via the seating means 70. The sheeting means 70 may be, for example, a sealant or an adhesive disposed or dispensed on the proximal surface of the friction layer that comes into contact with the waste and inner surface 69 and/or the inner surface 69. However, Applicant finds that it is desirable to provide a seating means as dovetail extensions or protrusions 70 of friction material to locate and expand the corresponding opening provided at the proximal end 22 of the cylindrical body 12. found.

Another feature that can be seen in the alternative embodiment illustrated in FIGS. 7-11, in particular in FIGS. 10 and 11, is a spring seating guide protrusion extending proximally from the proximal end 22 of the cylindrical body 12 at It is (72). This seating guide protrusion 72 is provided for an easy guide and proper seating of the spring 62 at the proximal end 22 of the cylindrical body 12.

Referring now to FIGS. 10 and 11 in more detail, the magnetic field generating holder 31 has a body 32 that substantially surrounds the magnet 8. In this embodiment, the holder body 32 comprises a skirt 36 positioned adjacent the distal end 35 of the holder body 32, the skirt 36 extending radially outward from the holder body 32. And an annular peripheral wall 37 extending distally from the peripheral edge 38 of the substantially planar surface. The annular peripheral wall 37 extends to the distal end and meets the distal end wall 73 and completely encloses the magnet 8 at the distal end. At the proximal end 34 of the magnetic field generating holder body 32, there are no protrusions on the teeth or bore 33 located in the body 32. Thus, in this arrangement, the skirt surface 36 of the holder body 32 forms an engagement means with the distal-facing surface of the friction layer 68 of the cylindrical body 12. The holder body 32 and the activation button body 54 are held together through frictional cooperation of the bore 33, which receives the holder engagement member 60. Optionally and advantageously, the bore 33 and the holder engagement member 60 are permanently connected together once assembled, for example via ultrasonic spot welding. Thus, in the engaged position, the spring 62 pulls the holder body 32 in a proximal direction towards the distal facing surface of the friction layer 68 due to the connection between the bore 33 and the engagement member 60. . When the spring reaches the uncompressed form, the skirt surface 36 of the holder body 32 makes contact with the distal facing surface of the friction layer 68 so that all rotational motion of the cylindrical body 12 is between the friction layer and the skirt surface. It is held in place to the extent that it is converted to the skirt surface 36 through friction induced in the. In this way, the magnet 8 is frictionally coupled to the cylindrical body, and any rotational movement of the cylindrical body connected to the dose wheel 21 of the drug delivery device causes the magnet to rotate. When the clutch activation button is pressed, for example, by the user's thumb or other finger, the button body 54 urges the spring 62 and pushes the button body 54 and holder body 32 axially and distal. By moving, causing separation of the skirt surface 37 of the holder body 37 from the friction layer 68, and moving the clutch assembly to the disengaged position, so that the holder body 32 from the cylindrical body 12 Axially, such as to activate the separation, resulting in injection through the proximity of the injection button at the proximal and distal end 35 of the holder body 32, without corresponding conversion of any rotational motion, for example with a dose setting wheel. Allows free and independent axial movement of the holder body.

Although two specific usage scenarios have been described in detail above, the selectively engageable and disengaged clutch assembly as generally described herein allows drug delivery device manufacturers to respond to the common MO of their drug delivery device. As a result, it is possible to configure the engagement and disengagement of the magnetic field generating means. This allows the dose control device comprising such a clutch assembly to control and verify the dose setting and actual amount of the administered drug through the use of known magnetic field detection sensors and associated data processing, as well as preventing misuse or at least dose control. It makes it a highly flexible tool that provides drug delivery device manufacturers with the possibility to detect misuse of the device, and is equally important, and equally advantageous, not forcing changes in the usage habits of users associated with a given drug delivery device. Does not.

Claims (44)

A dose control device for a handheld pen type injectable drug delivery device, wherein the handheld pen type injectable drug delivery device comprises an elongated body having a proximal end and a distal end, a longitudinal axis extending from the proximal end to the distal end, and A rotating dose setting wheel located at the proximal end, wherein the dose control device comprises:
Magnetic field generating means located at the proximal end of the elongated body;
One or more magnetic field sensors in communication with a data processing unit located inside or on an outer surface of the elongated body; And
And a clutch assembly configured to selectively move the magnetic field generating means from a first, engaged position to a second, disengaged, position. The method of claim 1,
The clutch assembly is
And a cylindrical body having a longitudinal inner bore, wherein the magnetic field generating means is located within the bore of the cylindrical body, the cylindrical body being removably mounted in an axial longitudinal alignment around the rotating dose setting wheel, and the rotating dose setting wheel Dose control device, rotatable together with. The method of claim 2,
The first, engaged, position is that the magnetic field generating means is held in the bore of the cylindrical body so that any rotational motion of the cylindrical body is directly transmitted to the magnetic field generating means to cause the magnetic field generating means to rotate. Position, dose control device. The method of claim 2,
The second, disengaged, position is a position in which the magnetic field generating means is held in the bore of the cylindrical body such that any rotational motion of the cylindrical body is not transmitted to the magnetic field generating means. The method according to any one of claims 2 to 4,
Wherein the cylindrical body has a distal end, the distal end mating with an outer surface of the dose setting wheel and configured to grip an outer surface of the dose setting wheel. The method according to any one of claims 2 to 5,
Wherein the cylindrical body has a proximal end, the proximal end configured to receive at least a portion of a clutch activation button. The method according to any one of claims 2 to 6,
Wherein the cylindrical body comprises a first annular wall extending within and along the bore to the proximal end. The method of claim 7,
The first annular wall is connected to the inner surface wall of the cylindrical body. The method according to claim 7 or 8,
The first annular wall is connected to the cylindrical body inner surface wall through a first annular skirt extending radially outwardly from the first inner annular wall to the cylindrical body inner surface wall. The method according to any one of claims 7 to 9,
Wherein the first annular wall, the first annular skirt and the cylindrical body inner surface wall form an annular groove for receiving at least a portion of a clutch activation button. The method according to any one of claims 7 to 10,
The first annular wall further comprises a second annular skirt, located at the proximal end of the first annular wall, projecting radially inwardly into the bore of the cylindrical body from the proximal end of the first annular wall , Dose control device. The method according to any one of claims 7 to 11,
The annular wall further comprises at least a pair of clutch tooth projections extending radially inwardly into the bore of the cylindrical body from an inner surface of the proximal end of the annular wall. The method according to any one of claims 7 to 11,
The second annular skirt further comprises a second annular wall extending from an inner end of the second annular skirt, the second annular wall being coaxially with the first annular wall toward the proximal end of the cylindrical body. Extending, dose control device. The method of claim 13,
The second annular wall comprises at least a pair of clutch tooth protrusions extending radially inwardly from an inner surface of the second annular wall into the bore of the cylindrical body. The method of claim 12 or 14,
The dose control device, wherein the distal end of each of the tooth protrusions of the at least one pair of clutch tooth protrusions has a narrower cross-section and/or profile than the cross-section of the tooth protrusion at a proximal end thereof. The method of claim 12 or 14,
The dose control device, wherein the distal end of each tooth protrusion of the at least one pair of clutch tooth protrusions is rounded. The method of claim 1,
The clutch assembly further comprises a magnetic field generating means holder. The method of claim 17,
Wherein the magnetic field generating means holder comprises a holder body having a longitudinal bore, a proximal end and a distal end. The method of claim 18,
The magnetic field generating means holder body comprises a magnetic field generating means material. The method of claim 17,
The holder body comprises a skirt and is positioned adjacent the distal end of the holder body, the skirt being a substantially planar surface extending radially outwardly from the holder body and from a peripheral edge of the substantially planar surface to the end. A dose control device comprising an extending annular peripheral wall. The method of claim 20,
The skirt comprises at least one seating means for said magnetic field generating means located within an inner volume defined by said skirt, said seating means for receiving and seating said magnetic field generating means within said skirt. Configured, dose control device. The method according to any one of claims 17 to 21,
The holder body further comprises an array of clutch tooth protrusions extending radially outwardly in a spaced relationship from the outer peripheral surface of the holder body and positioned around the outer peripheral surface of the holder body. The method of claim 22,
The array of clutch tooth protrusions is optionally engageable with at least a pair of clutch tooth protrusions and at least a pair of clutch tooth protrusions extending radially inwardly from the inner surface of the proximal end of the annular wall of the cylindrical body. Dose control device that can be disengaged from The method according to any one of claims 18 to 23,
The holder body further comprising an activation button engagement member configured to engage and hold the clutch activation button. The method of claim 24,
Wherein the clutch activation button engagement member is located within the bore of the holder body adjacent a proximal end thereof. The method according to any one of claims 1 to 16,
Wherein the clutch assembly further comprises a clutch activation button. The method of claim 26,
The clutch activation button has a distal end comprising a distal surface, and in the clutch assembly disengaged position, the distal surface is in contact with a corresponding proximal surface located at the proximal end of the cylindrical body, and the clutch assembly In an engaged position, the distal surface of the distal end of the clutch activation button is no longer in contact with the corresponding proximal surface located at the proximal end of the cylindrical body. The method of claim 26,
The clutch activation button comprises a button body, the button body extending from a proximal end toward a distal end of the button body, the button body comprising an annular wall extending distally along a longitudinal axis of the button body, The annular wall has a diameter smaller than the diameter of the button body so that it is spaced from the proximal end of the button body and forms a distal shoulder at a distal position, and the distal shoulder is the cylindrical at the disengaged position of the clutch assembly. A dose control device dimensioned to contact a corresponding proximal surface located at the proximal end of the body. The method of claim 28,
The annular wall of the activation button body, at the clutch assembly disengaged position, is in contact with an annular groove formed by the first annular wall, the first annular skirt and the inner surface wall of the cylindrical body. Having a dose control device. The method of claim 28,
Wherein the annular wall of the activation button body defines an inner, inner, substantially cylindrical volume of the annular wall, the inner volume having an open distal end and a closed proximal end. The method according to any one of claims 26 to 30,
Wherein the activation button comprises a holder engagement member, configured to hold and engage an activation button engagement member provided on the magnetic field generating means holder. The method of claim 2,
The clutch assembly further comprises a pre-constrain bias member positioned between the clutch activation button and the annular skirt projecting radially inwardly from the annular wall adjacent the proximal end of the cylindrical body. device. The method of claim 32,
The pre-pressed biasing member is placed distal to the annular skirt of the annular wall of the cylindrical body and proximally with respect to the closed proximal end of the inner volume of the activating button into the inner, substantially cylindrical volume. Inserted, dose control device. The method of claim 32 or 33,
Wherein the pre-pressed bias member adopts a relatively uncompressed form in the engaged clutch assembly position, and adopts a relatively urged form in the disengaged clutch assembly position. The method of claim 34,
In the disengaged clutch assembly position, the pre-pressed bias member is compressed. The method of claim 34,
In the engaged clutch assembly position, the pre-pressed bias member is relieved. The method of claim 34,
Application of a distal direction force to the clutch activation button causes compression of the pre-pressed bias member, thereby causing the protruding teeth of the holder to disengage the bias and disengage in contact with the corresponding protruding teeth of the cylindrical body. And moving the distal end surface of the activating button annular wall to contact the annular groove formed by the annular wall, the annular skirt and the cylindrical body inner surface wall. The method of claim 34,
Relief of compression for the pre-pressed bias member is relatively uncompressed or expanded in a relaxed form, causing the clutch activation button to move proximally, and the holder engagement member and the activation button engagement The dose control device, wherein the engagement connection between the members also causes the holder to move proximally, thereby engaging the protruding teeth of the holder into a bias contact with the corresponding protruding teeth of the cylindrical body. The method of claim 32,
The dose control device, wherein the pre-compression bias member is a spring. The method of claim 32,
The dose control device, wherein the pre-pressed bias member is a flat wire compression spring or a wave spring. The method according to any one of claims 1 to 11, 13, 17 to 21, 24 to 36, or 39,
Wherein the cylindrical body further comprises a friction layer located on the inner wall of the proximal end. The method of claim 41,
Wherein the friction layer comprises a thermoplastic elastomer gel. The method of claim 41 or 42,
The friction layer overlying an opening provided at the proximal end of the cylindrical body. The method according to any one of claims 41 to 43,
The dose control device, wherein the magnetic field generating means holder body skirt surface is selectively engageable with the friction layer provided in the cylindrical body and disengageable from the friction layer.

Images